As-needed administration of an androgenic agent to enhance female desire and responsiveness

Abstract

A method is provided for enhancing a female individual's sexual desire and responsiveness. The method involves administration of a pharmaceutical formulation containing an effective amount of an androgenic agent, wherein administration is on an as-needed basis rather than involving chronic pharmacotherapy. Local delivery may be accomplished via administration to the vagina, vulvar area or urethra of the individual, although oral administration is preferred for those androgenic agents that are orally active. Formulations and kits for carrying out the method are provided as well.

Description

TECHNICAL FIELD This invention relates generally to methods and pharmaceutical formulations for enhancing female sexual desire and responsiveness, and more particularly, relates to the use of an androgenic agent in such methods and formulations. BACKGROUND Sexual response in women is generally classified into four stages: excitement, plateau, orgasm, and resolution. Masters and Johnson, Human Sexual Response (Boston, Mass.: Little, Brown & Co., 1966). With sexual arousal and excitement, vasocongestion and muscular tension increase progressively, primarily in the genitals, and is manifested by increased blood flow, elevated luminal oxygen tension, and vaginal surface lubrication as a result of plasma transudation that saturates the fluid reabsorptive capacity of the vaginal epithelium. Sexual excitement is initiated by any of a number of psychogenic or somatogenic stimuli and must be reinforced to result in orgasm. With continued stimulation, excitement progresses in intensity into...

AI Technical Summary

Benefits of technology

Accordingly, the present invention is addressed to the aforementioned need in the art, and provides a novel way to enhance female sexual desire and responsiveness, wherein drug administration is on an “as-needed” basis rather than involving chronic pharmacotherapy, and is highly effective in the vast majority of women. The method is premised on the generally accepted principle that testosterone is the primary hormone responsible for sexual desire in women, and that elevated testosterone levels, typically occurring approximately midway through the menstrual cycle, correlate with increased sexual desire. The method, compositions and dosage forms of the invention not only enhance female sexual desire and responsiveness, but are also useful in improving the tissue health of the female genitalia and preventing vaginal atrophy, preventing pain during intercourse as a result of dyspareunia, and alleviating vaginal itching and dryness associated with dyspareunia and other conditions.

In order to carry out the method of the invention, a selected androgenic agent is administered to a female individual to enhance sexual desire and responsiveness, and / or to improve tissue health of the female genitalia, prevent vaginal atrophy, prevent pain during intercourse, and alleviate vaginal itching and dryness; the individual may or may not be suffering from a sexual disorder or dysfunction. The active agent may be administered orally, topically or transmucosally, transdermally, by inhalation, or using any other route of administration. Oral administration, because of its convenience, is preferred for those active agents that have sufficient oral bioavailability. For other active agents, the preferred mode of administration involves vaginal delivery and / or topical application to the clitoris and the surrounding vulvar region.

Problems solved by technology

In addition, estrogen deficiency, causing vaginal atrophy and dyspareunia, is a common cause of sexual dysfunction.

Such excitement phase dysfunction generally results in dyspareunia.

Dyspareunia is thought to affect approximately 40% of women, due in large part to inadequate lubrication.

This effect may lead to an undesirable increase in the production of certain coagulation factors and renin substrates by the liver.

However, all estrogen-based therapies are known to increase the risk of endometrial hyperplasia endometrial cancer and breast cancer in treated individuals.

However, common side effects from administration of such combinations include uterine bleeding and the continuation of menstrual periods.

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